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NCT Number: NCT04530045

Target Attainment of TDM-guided Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients

Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes.

Therapeutic drug management (TDM) guided dosing is the only safe and effective way to ensure that all critically ill patients achieve therapeutic antimicrobial exposures and to minimise the likelihood of toxicity.

For experts, TDM should be a standard of care, in particular for β-lactams. Nevertheless, because of the assay method for β-lactams and the need for bioanalytical experts, delays in obtaining results frequently occurred. These barriers, combined with difficulties in the interpretation of TDM results, need to be addressed in order to increase its routine utilization. Consequently, study aiming at identify which subgroup of patients or infection are more likely to benefit from TDM are urgently warranted This prospective observational study aimed at evaluating target attainment of piperacillin/tazobactam (PIP/TAZ) and cefepim (CEF) with the use of a Therapeutic Drug Monitoring (TDM) in critically patients during the routine care

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Key information

Conditions

Critical Illness Antibiotic Toxicity Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emmanuel NOVY, Vandœuvre-lès-Nancy, Lorraine, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimun age limits 18 years
  • Critically ill patient receiving piperacillin or cefepim administered continuously

Exclusion criteria

  • Beta lactam allergy
  • Pregnancy
  • Age less than 18 years

Treatment and study plan

dosage of concentration of piperacillin and cefepim

Other

Dosage of total plasma concentration of piperacillin and cefepim at different timepoints

Primary outcomes

  1. to determine the percentage of patients who met the PK/PD targets at 24 hours

    Time frame: Day 1

    PK/PD target was defined as follows:

    Concentration of piperacillin or cefepim between a lower and a upper limit:

    • The lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria
    • The upper limit was based on known limit of neurotoxicity, namely 35 and 160 mg/L for cefepim and piperacillin, respectively

    Consequently :

    • for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is between 32 and 160 mg/l
    • for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is between 4 and 35 mg/l

Secondary outcomes

  1. to determine the percentage of patients who met the PK/PD targets "exposure" at 24 hours

    Time frame: Day 1

    PK/PD target "exposure" take into account only the the lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria

    Consequently :

    • for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is above 32 mg/l
    • for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is above 4 mg/l

  2. factors associated with target attainment at day 1

    Time frame: Statistical analysis after 2 years of inclusion

    effect of age on antibiotic concentration

  3. factors associated with target attainment at day 1

    Time frame: Statistical analysis after 2 years of inclusion

    effect of renal clearance on antibiotic concentration

  4. factors associated with target attainment at day 1

    Time frame: Statistical analysis after 2 years of inclusion

    effect of presence of septic shock on antibiotic concentration

  5. factors associated with dose changing

    Time frame: Statistical analysis after 2 years of inclusion

    effect of presence of septic shock on number of dose changing after analyse of antibiotic concentration

  6. factors associated with dose changing

    Time frame: Statistical analysis after 2 years of inclusion

    effect of renal clearance on number of dose changing after analyse of antibiotic concentration

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Target Attainment of TDM-guided Continuous Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients: a Prospective Observational Study

Acronym: DOSATB

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2020
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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